Circulating Tumor DNA Monitoring in Breast Cancer Undergoing Neoadjuvant Therapy

February 22, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
In the prospective, open, observational study, we aim to evaluate whether circulating tumor DNA (ctDNA) can be the marker of the response to neoadjuvant therapy in stage I-III breast cancer.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
        • Principal Investigator:
          • Yiding Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with stage I-III breast cancer

Description

Inclusion Criteria:

  • Patient is ≥ 18 years-old at the time of consent to participate this trial
  • Patients with stage I-III invasive breast cancer
  • No prior anti-cancer treatment
  • Felt to be a possible candidate for neoadjuvant therapy by their physician

Exclusion Criteria:

  • Known to have other aggressive malignant tumor in the past 5 years.
  • Breast cancer during lactation; Inflammatory breast cancer; Acute inflammatory disease, pregnancy and other conditions may affect the levels of ctDNA and/or peripheral inflammatory indicators.
  • There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
  • The investigator determines that subjects are not appropriate to participate in the study due to other factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients receiving neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Miller-Payne grading system
Time Frame: 3 years
3 years
Residual cancer burden (RCB)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

GeneCast Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2021

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2025

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0532

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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